Needleless injection site

ABSTRACT

A needleless injection site comprising a housing defining proximal and distal ends and including a reseal member disposed therein. The reseal member has an elastically openable and closable aperture formed therein, and normally resides within the housing in a closed position wherein the aperture is in a closed configuration. The reseal member is deformable such that the application of distally directed pressure thereto will cause the reseal member to distally advance within the housing to an open position wherein the aperture assumes an open configuration. The removal of the distally directed pressure from the reseal member will cause it to resiliently return to the closed position wherein the aperture assumes the closed configuration.

This application is a continuation of application Ser. No. 09/849,091filed May 4, 2001 now U.S. Pat. No. 6,572,591 which is a continuation ofapplication Ser. No. 09/226,664 filed Jan. 8, 1999, now U.S. Pat. No.6,261,268, which is a continuation of application Ser. No. 08/550,748filed Oct. 31, 1995, now U.S. Pat. No. 5,788,675, which is a divisionalof application Ser. No. 08/262,994 filed Jun. 20, 1994, now U.S. Pat.No. 5,470,319.

FIELD OF THE INVENTION

The present invention relates generally to the medical arts, and moreparticularly to a needleless injection site for use in relation tointravenous infusions.

BACKGROUND OF THE INVENTION

It is common medical practice to intravenously infuse various fluidsinto the blood vessels of a patient. Such infusion is typicallyaccomplished by the insertion of a hollow introducer needle into atarget blood vessel. The introducer needle is fluidly connected to oneend of an elongate, flexible tube, the opposite end of which is fluidlyconnected to a solution bag. The solution bag itself is typicallysuspended above the patient so as to allow the fluid to flow downwardlythrough the tubing and into the patient's blood vessel via theintroducer needle which remains operatively positioned therewithin. Thefluid tube and solution bag are connected to each other via a meteringapparatus which controls the infusion rate of fluid from the bag intothe tube.

In many intravenous infusion assemblies, an injection site is fluidlycoupled within the tubing intermediate the introducer needle and thesolution bag. The injection site typically has a Y-shaped configurationand comprises a tubular main body portion having a tubular side armportion in fluid communication therewith. The distal end of the side armportion is fluidly connected to the solution bag via an upper segment ofthe tubing, with the bottom end of the main body portion being fluidlyconnected to the introducer needle via a lower segment of the tubing.The top end of the main body portion is itself covered by a diaphragmwhich is typically fabricated from rubber or a similar resilientmaterial.

The inclusion of the injection site within the tubing allows variousmedications to be selectively infused into the blood vessel of thepatient by the addition thereof to the solution flowing from thesolution bag into the blood vessel via the upper tubing segment,injection site, lower tubing segment and introducer needle. Thissupplemental infusion is typically accomplished through the utilizationof a conventional syringe, the needle of which pierces and is extendedthrough the diaphragm disposed on the top end of the main body portionof the injection site. Subsequent to the expulsion of the medicationfrom within the syringe and into the flowing solution, the needle isretracted out of the main body portion of the injection site, with theaperture created in the diaphragm due to the passage of the needletherethrough being substantially closed upon such retraction due to theresiliency of the diaphragm. As will be recognized, the incorporation ofthe injection site within the tubing allows various medications to beintravenously administered to the patient through the existing infusionsite within the blood vessel, thus eliminating the need to subject thepatient to additional needle sticks.

Through providing certain benefits to the patient, the injection sitesconstructed in accordance with the prior art possess certaindeficiencies which detract from their overall utility. As previouslyexplained, the use of such injection sites typically requires that theneedle of a conventional syringe be extended through (i.e. puncture) thediaphragm attached to the top end of the main body portion of theinjection site. However, the necessity of having to utilize a syringewith a needle to facilitate the introduction of the medication into thesolution flow is undesirable due to the risk of inadvertent needlesticks. In recognition of this deficiency, there has also been developedin the prior art needleless injection sites which incorporate adiaphragm adapted to assume open and closed configurations withouthaving a needle inserted thereinto. Though these needleless injectionsites eliminate the need of having to puncture the diaphragm with aneedle, they also possess certain deficiencies which detract from theiroverall utility. Foremost of these deficiencies is the difficultyassociated with disinfecting the injection site, and, in particular thediaphragm thereof, subsequent to medication being infused thereinto. Inthis respect, after each use of the injection site the diaphragm must becleaned, with such cleaning typically being accomplished through theapplication of alcohol or a similar disinfecting substance thereto.However, due to the configuration of the diaphragm, complete andeffective disinfection thereof is often difficult to achieve, thusincreasing the risk of the introduction of contaminates into thesolution stream upon subsequent uses of the injection site. The presentinvention is adapted to overcome these and other deficiencies associatedwith prior art injection sites.

SUMMARY OF THE INVENTION

In accordance with a first embodiment of the present invention, there isprovided a needleless injection site comprising a housing. The housingitself comprises a main body portion defining proximal and distal ends,and a bore extending axially therethrough. The housing further comprisesa tubular side arm portion which is in fluid communication with the mainbody portion.

Attached to the proximal end of the main body portion is a reseal memberwhich extends into the bore and includes an elastically openable andclosable aperture formed therein. The reseal member normally resides ina closed position wherein the aperture is in a closed configuration. Inthe first embodiment, the reseal member is deformable such that theapplication of distally pressure thereto will cause it to distallyadvance within the bore to an open position wherein the aperture assumesan open configuration. Conversely, the removal of the distally directedpressure from the reseal member will cause it to the resiliently returnto the closed position wherein the aperture assumes the closedconfiguration.

The reseal member is preferably fabricated from silicone and comprises acircularly configured proximal portion which defines a top surface andhas a flange formed about the periphery thereof for attaching the resealmember to the main body portion of the housing. The reseal memberfurther comprises a cylindrically configured central portion whichdefines a side surface and a bottom surface having a conically shapednotch formed therein. The aperture extends from the top surface of theproximal portion to the apex of the notch. In addition to the proximaland central portions, the reseal member includes a tubular distalportion which is invertible and adapted to overlap the side surface ofthe central portion and apply a radially inward biasing force theretowhen inverted which maintains the aperture in the closed configurationwhen no distally directed pressure is applied to the top surface of theproximal portion.

The injection site of the first embodiment further comprises a lock ringfor securing the reseal member to the proximal end of the main bodyportion. In this respect, the flange of the reseal member is rigidlycaptured between the main body portion and the lock ring. Additionally,formed on the outer surface of the main body portion adjacent theproximal end thereof are Luer threads.

In accordance with a second embodiment of the present invention, thereis provided a needleless injection site comprising a housing which alsocomprises a main body portion defining proximal and distal ends and abore extending axially therethrough. Formed on the proximal end of themain body portion and extending axially therefrom is an elongate dilatorprojection. The dilator projection defines a longitudinally extendingfluid passage which is in fluid communication with the bore. Attached tothe proximal end of the main body portion is a connector cap whichdefines a central opening into which the dilator projection extends. Thehousing further comprises a tubular side arm portion which is in fluidcommunication with the main body portion.

Disposed within the opening of the connector cap is a reseal memberwhich has an elastically openable and closable aperture formed therein,and normally resides in a closed position wherein the aperture is in aclosed configuration. The dilator projection of the housing extends intothe reseal member. The reseal member is deformable such that theapplication of distally directed pressure thereto will cause it todistally advance within the opening to an open position wherein theaperture is forced over a portion of the dilator projection. Conversely,the removal of the distally directed pressure from the reseal memberwill cause it to resiliently return to the closed position wherein theaperture assumes the closed configuration.

In the second embodiment, the reseal member is attached to the connectorcap and comprises a circularly configured proximal portion which definesa top surface and has a flange formed about the periphery thereof forattaching the reseal member to the connector cap. The reseal memberfurther comprises a cylindrically configured central portion whichdefines a side surface and a bottom surface having an elongate,generally concave recess formed therein which is sized and configured toreceive the dilator projection. The aperture extends from the topsurface of the proximal portion to the apex of the recess. In additionto the proximal and central portions, the reseal member includes atubular distal portion which is invertible and adapted to overlap theside surface of the central portion and apply a radially inward biasingforce thereto when inverted which maintains the aperture in the closedconfiguration when no distally directed pressure is applied to the topsurface of the proximal portion. Like the reseal member previouslydescribed in relation to the first embodiment, the reseal memberconstructed in accordance with the second embodiment is preferablyfabricated from silicone. Additionally, the reseal member is preferablycooperatively engaged to the dilator projection and disposed in abuttingcontact with the proximal end of the main body portion.

The connector cap of the housing includes Luer threads formed on theouter surface thereof adjacent the central opening. Additionally, themain body portion of the housing normally resides in a first positionwithin the connector cap, and is adapted to move distally relative theconnector cap to a second position therewithin when distally directedpressure is applied to the reseal member. The removal of the distallydirected pressure from the reseal member causes the main body portion toresiliently return to the first position. The main body portionpreferably includes a leaf spring molded thereon which is cooperativelyengaged to the connector cap and adapted to bias the main body portionto the first position.

In accordance with a third embodiment of the present invention, there isprovided a needleless injection site comprising a housing. The housingitself comprises an adapter member defining proximal and distal ends,and an interior chamber. Formed on the proximal end of the adaptermember is an elongate dilator projection which defines a proximalportion extending axially from the proximal end, a distal portionextending axially into the interior chamber, and a longitudinallyextending fluid passage in fluid communication with the interiorchamber. Attached to the adapter member is a connector cap which definesa central opening. The adapter member is disposed within the connectorcap, with the proximal portion of the dilator projection extending intothe opening thereof.

Disposed within the opening is a reseal member which has an elasticallyopenable and closable aperture formed therein, and normally resides inthe closed position wherein the aperture is in a closed configuration.The proximal portion of the dilator projection extends into the resealmember. The reseal member is deformable such that the application ofdistally directed pressure thereto will cause it to distally advancedwithin the opening to an open position wherein the aperture is forcedover the proximal portion of the dilator projection. Conversely, theremoval of the distally directed pressure from the reseal member willcause it to resiliently return to the closed position wherein theaperture assumes the closed configuration. The reseal member, which isalso preferably fabricated from silicone, comprises a tubular proximalportion and a cylindrically configured distal portion defining top,bottom and side surfaces, and including an elongate, generally concaverecess formed in the bottom surface thereof which is sized andconfigured to receive the proximal portion of the dilator projection.The aperture extends from the top surface of the distal portion to theapex of the recess. The proximal portion is invertible and adapted tooverlap the side surface of the distal portion and apply a radiallyinward biasing force thereto when inverted which maintains the aperturein the closed configuration when no distally directed pressure isapplied to the top surface of the distal portion. The reseal member ispreferably cooperatively engaged to the proximal portion of the dilatorprojection and disposed in abutting contact with the proximal end of theadapter member.

The connector cap of the housing constructed in accordance with thethird embodiment also includes Luer threads formed on the outer surfacethereof adjacent the central opening. Additionally, the adapter membernormally resides in a first position within the connector cap, and isadapted to move distally relative the connector cap to a second positiontherewithin when distally directed pressure is applied to the resealmember. When the distally directed pressure is removed from the resealmember, the adapter member resiliently returns to the first position.The adapter member preferably includes a leaf spring molded thereonwhich is cooperatively engaged to the connector cap and adapted to biasthe adapter member to the first position.

In the first embodiment, the distal portion of the dilator projectionhas a tapered outer surface for facilitating the connection of theadapter member and hence the housing to a tubular fluid line. Inparticular, the housing is connected to the fluid line via the insertionof the distal portion of the dilator projection into the lumen of thefluid line, with the distal portion being frictionally retained withinthe lumen subsequent to being inserted thereinto.

The adapter member further comprises a tubular adapter sleeve which isslidably extensible over and frictionally maintainable on the distalportion of the dilator projection for facilitating the connection of thehousing to a Luer connector. The housing is connected to the Luerconnector via the insertion of the adapter sleeve into the lumen of theLuer connector. The distal portion of the dilator projection preferablyhas a tapered outer surface, with the adapter sleeve preferably having atapered bore extending longitudinally therethrough which iscomplimentary to the outer surface of the distal portion of the dilatorprojection, thus facilitating the frictional retention of the adaptersleeve thereon. Additionally, the distal portion of the dilatorprojection preferably includes an elongate rib formed on the outersurface thereof, with the bore of the adapter sleeve defining anelongate slot therewithin which is sized and configured to receive therib when the adapter sleeve is slidably advanced over the distal portionof the dilator projection. The receipt of the rib into the slot isoperable to prevent the rotation of the adapter sleeve upon the distalportion of the dilator projection. Further, the adapter sleevepreferably has a tapered outer surface for frictionally retaining theadapter sleeve within the lumen of the Luer connector subsequent tobeing inserted thereinto.

The adapter member of the housing further defines a tubular lock regionwithin the distal end thereof which is configured to engage the Luerthreads of the Luer connector when the adapter sleeve is inserted intothe lumen thereof. The lock region preferably defines a plurality ofLuer thread pitch barbs therewithin which engage the Luer threads. Thelock region of the adapter member is also used to facilitate theconnection of the housing to a Y-injection site. In particular, thehousing is connected to the Y-injection site via the insertion of theY-injection site into the lock region of the adapter member, and theextension of the distal portion of the dilator projection thereinto. Inthe third embodiment, the adapter member preferably comprises an uppersection defines the dilator projection, and a lower section which isrigidly attached to the upper section and defines the lock region, withthe upper and lower sections defining the interior chamber when attachedto each other.

Further in accordance with the present invention, there is provided amethod of fabricating a reseal member for use in a needleless injectionsite. The method comprises the step of molding the reseal member toinclude a circularly configured proximal portion, a cylindricallyconfigured central portion having an opening formed in the bottomsurface thereof, an aperture extending from the top surface of theproximal portion to the opening, and a tubular distal portion. Themethod further comprises the step of inverting the distal portion in amanner causing it to overlap the side surface of the central portion andapply a radially inward biasing force thereto which maintains theaperture in a closed configuration. The method may further comprise thestep of forming a flange about the periphery of the proximal portion.The opening formed within the central portion may comprise aconically-shaped notch, with the aperture extending from the top surfaceof the proximal portion to the apex of the notch. Alternatively, theopening may comprise an elongate, concave recess, with the apertureextending from the top surface of the proximal portion to the apex ofthe recess.

There is also provided a method of fabricating a reseal member for usein a needleless injection site which comprises the step of molding thereseal member to include a tubular proximal portion, a cylindricallyconfigured distal portion having a concave recess formed in the bottomsurface thereof, and an aperture extending from the top surface of thedistal portion to the apex of the recess. The method further includesthe step of inverting the proximal portion in a manner causing it tooverlap the side surface of the distal portion and apply a radiallyinward biasing force thereto which maintains the aperture in a closedconfiguration.

BRIEF DESCRIPTION OF THE DRAWINGS

These, as well as other features of the present invention, will becomemore apparent upon reference to the drawings wherein:

FIG. 1 is a perspective view of a needleless injection site constructedin accordance with a first embodiment of the present invention;

FIG. 2 is a cross-sectional view taken along line 2-2 of FIG. 1;

FIG. 2 a is a cross sectional view of the reseal member;

FIG. 3 is a cross-sectional view of the reseal member incorporated intothe needleless site shown in FIG. 1;

FIG. 4 is a perspective view of the reseal member shown in FIG. 3;

FIG. 5 is a cross-sectional view illustrating the manner in which thereseal member is deformable from a closed to an open position;

FIG. 6 is a side elevational view of a needleless injection siteconstructed in accordance with a second embodiment of the presentinvention, and further illustrating various devices which may beconnected thereto;

FIG. 7 is a cross-sectional view of the reseal member incorporated intothe needleless injection site shown in FIG. 6;

FIG. 8 is an exploded perspective view of the main body portion andreseal member of the needleless injection site shown in FIG. 6;

FIG. 9 is a partial cross-sectional view of the needleless injectionsite shown in FIG. 6, with the reseal member thereof being in a closedposition;

FIG. 10 is a partial cross-sectional view of the needleless injectionsite shown in FIG. 6, with the reseal member thereof being deformed intoan open position;

FIG. 11 is a side elevational view of a needleless injection siteconstructed in accordance with a third embodiment of the presentinvention, and further illustrating a Luer connector and a tubing end towhich it may be connected;

FIG. 12 is a side elevational view of the needleless injection siteconstructed in accordance with the third embodiment of the presentinvention as connected to a bottle;

FIG. 13 is a cross-sectional view of the reseal member incorporated intothe needleless injection site shown in FIGS. 11 and 12;

FIG. 14 is an exploded perspective view of the needleless injection siteconstructed in accordance with the third embodiment of the presentinvention;

FIG. 15 is a cross-sectional view of the needleless injection site shownin FIGS. 11 and 12 as connected to a Luer connector, with the resealmember thereof being deformed into an open position;

FIG. 16 is a cross-sectional view of the needleless injection site shownin FIGS. 11 and 12 as connected to a Y-injection site, with the resealmember thereof being deformed into an open position; and

FIG. 17 is a cross-sectional view of the needleless injection site shownin FIGS. 11 and 12 as connected to a tubular fluid line, with the resealmember thereof being in a closed position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings wherein the showings are for purposes ofillustrating preferred embodiments of the present invention only, andnot for purposes of limiting the same, FIG. 1 perspectively illustratesa needleless injection site 10 constructed in accordance with a firstembodiment of the present invention. In the first embodiment, theinjection site 10 comprises a Y-shaped housing 12. The housing 12 itselfcomprises a main body portion 14 which defines a proximal end 16, adistal end 18 and a bore 20 extending axially therethrough. The housing12 further comprises a tubular side arm 22 portion which extendsangularly from the main body portion 14 and defines a bore 24 in fluidcommunication with the bore 20 of the main body portion 14. In typicalintravenous infusion applications, the side arm portion 22 is fluidlyconnected to a suspended solution bag via an upper segment of tubularfluid line. The distal end 18 of the main body portion 14 is itselffluidly connected to a hollow introducer needle via an elongate lowersegment of tubular fluid line, thus allowing the solution to flow fromthe bag into a target blood vessel via the upper tubing segment,injection site 10, lower tubing segment and introducer needle.

Referring now to FIGS. 2-5, attached to the proximal end 16 of the mainbody portion 14 is a reseal member 26 which is fabricated from aresilient material and extends into the bore 20. As best seen in FIGS. 3and 4, the reseal member 26 comprises a circularly configured proximalportion 28 which defines a top surface 30 and includes a flange 32formed about the periphery thereof. The reseal member 26 furthercomprises a cylindrically configured central portion 34 which defines aside surface 36 and a bottom surface 38 having a conically shaped notch40 formed in the center thereof. In addition to the proximal and centralportions 28, 34, the reseal member 26 comprises a tubular distal portion42 which includes an annular lip 44 formed about the inner surfacethereof. The distal portion 42 is preferably formed in a manner whereina slit 46 is disposed in the comer region defined between the lip 44 andthe remainder of the distal portion 42. Extending from the top surface30 of the proximal portion 28 to the apex of the notch 40 is an aperture48 which is elastically openable and closable. In the injection site 10,the reseal member 26 normally resides in a closed position wherein theaperture 48 is in a closed configuration.

To maintain the aperture 48 in the closed configuration, the distalportion 42 of the reseal member 26 is formed so as to be invertible inrelation to the remainder thereof. As best seen in FIGS. 2 and 5, thedistal portion 42, when inverted, is adapted to overlap the side surface36 of the central portion 34 and apply a radially inward biasing forcethereto which maintains the aperture in the closed configuration. Suchinversion is accomplished by initially turning the lip 44 outwardly,thus causing the same to extend radially outward with respect to theremainder of the distal portion 42. The outward turning of the lip 44 isaided by the inclusion of the slit 46 within the distal portion 42.Thereafter, the distal portion 42 is rolled toward the proximal portion28, with the lip 44 being inserted into the annular channel 50 definedbetween the proximal and central portions 28, 34. When the distalportion 42 is properly inverted, the reseal member 26 assumes theconfiguration shown in FIG. 2. For ease of manufacture, the resealmember 26 is molded in the form shown in FIGS. 3 and 4, with the distalportion 42 thereof being inverted in the aforementioned manner prior tothe attachment of the reseal member 26 to the proximal end 16 of themain body portion 14. As previously explained, due to the resiliency ofthe material from which the reseal member 26 is fabricated, theinversion of the distal portion 42 facilitates the application of aradially inward biasing force to the central portion 34, thusmaintaining the aperture 48 in the closed configuration.

In the injection site 10, the housing 12 further comprises an annularlock ring 52 for securing the reseal member 26 to the proximal end 16 ofthe main body portion 14. In particular, the attachment of the resealmember 26 to the main body portion 14 is accomplished by the rigidcapture of the flange 32 between the main body portion 14 and lock ring52 which is itself attached to the main body portion 14 via a sonicbonding process. When attached to the main body portion 14 via the lockring 52, the central portion 34 of the reseal member 26 (which iscovered by the inverted distal portion 42) resides within the bore 20.

The reseal member 26, due to its construction, is deformable such thatthe application of distally directed pressure thereto will cause it todistally advance within the bore 20 to an open position wherein theaperture 48 assumes an open configuration (as shown in FIG. 5).Conversely, the removal of the distally directed pressure from thereseal member 26 will cause it to resiliently return to the closedposition wherein the aperture 48 assumes the closed configuration. Inparticular, when the reseal member 26 is in the closed position (asshown in FIG. 2), the top surface 30 of the proximal portion 28 extendsover (i.e., covers) the proximal end 16 of the main body portion 14,with the aperture 48 being in the closed configuration due to theradially inward biasing force applied to the central portion 34 by theinverted distal portion 42. When the tip 54 of an introducer device 56is used to apply distally directed pressure to the top surface 30 of theproximal portion 28, such pressure application causes the reseal member26 (with the exception of the flange 32) to distally advance within thebore 20 (as shown in FIG. 5). Due to the rigid attachment of the flange32 to the proximal end 16 of the main body portion 14 via the lock ring52, the advancement of the reseal member 26 distally within the bore 20causes the aperture 48 to assume the open configuration, which allowsfluid to flow from the outlet passage 58 of the introducer device 56into the bore 20 via the pathway defined by the open aperture 48 andnotch 40. Additionally, due to the resiliency of the reseal member 26,the removal of the introducer device 56 from within the injection site10 allows it to resiliently return to its closed position (shown in FIG.10), thus causing the aperture 48 to once again assume the closedconfiguration. In this respect, when no distally directed pressure isapplied to the top surface 30 of the proximal portion 28, the aperture48 is maintained in the closed configuration by the radially inwardbiasing force exerted on the central portion 34 by the inverted distalportion 42. The tip 54 of the introducer device 56 is preferably sizedhaving an outer diameter dimension which is slightly less than the innerdiameter dimension of the bore 20, thus allowing the stretched region ofthe proximal portion 28 to form a seal between the outer surface of thetip 54 and inner surface of the bore 20.

In the injection site 10, the reseal member 26 is preferably fabricatedfrom silicone, through similar elastic materials such as rubber may beutilized as an alternative. Additionally, the outer surface of the mainbody portion 14 preferably includes Luer threads 60 formed thereonadjacent the proximal end 16 to allow introducer devices such as Luerconnectors to be interfaced to the injection site 10. Advantageously,the uniform top surface 30 defined by the proximal portion 28 when thereseal member 26 is in the closed position allows for the quick and easycleaning and disinfection thereof. Though the reseal member 26 has beendescribed as being used in conjunction with the Y-shaped housing 12, itwill be recognized that the reseal member 26 may also be used inassociation with a Luer connector, a conventional tubular fluid line orany other type of injection site.

Referring now to FIG. 2 a, there is depicted a reseal member 26 a whichis adapted to be attached to the proximal end of an alternative Y-shapedhousing 12 a. The reseal member 26 a is substantially identical to thereseal member 26 previously described and comprises a circularlyconfigured proximal portion 28 a which defines a top surface 30 a andincludes the flange 32 a formed about the periphery thereof. The resealmember 26 a further comprises a cylindrically configured central portion34 a which defines a bottom surface 38 a having a conically shaped notch40 a formed in the center thereof and a side surface which is overlappedby an inverted, tubular distal portion 42 a. Extending from the topsurface 30 a of the proximal portion 28 a to the apex of the notch 40 ais an aperture 48 a which is elastically openable and closable. The onlydistinction between the reseal member 26 a and the reseal member 26 isin the configuration of the flange 32 a which is substantially longerthan the flange 32 for reasons which will be discussed below.

The housing 12 a to which the reseal member 26 a is attached is similarto the housing 12 previously described but does not include the Luerthreads 60 a formed on the outer surface on the main body portion 14 athereof. Rather, the proximal portion of the main body portion 14 a ofthe housing 12 a defines a generally smooth outer surface over which theflange 32 a is extended. As an alternative to the lock ring 52previously described, the housing 12 a further comprises an annular lockring 52 a for securing the reseal member 26 a to the proximal end of themain body portion 14 a. In particular, the attachment of the resealmember 26 a to the main body portion 14 a is accomplished by the rigidcapture of the flange 32 a between the main body portion 14 a and lockring 52 a which is itself attached to an annular shoulder 53 a formedabout the outer surface of the main body portion 14 a via a sonicbonding process. The outer surface of the lock ring 52 a preferablyincludes Luer threads 60 a formed thereon to allow introducer devicessuch as Luer connectors to be interfaced to the housing 12 a.

Though not shown, it will be recognized that alternative means may beutilized to apply a radially inward biasing force to the central portion34, 34 a of the reseal member 26, 26 a to maintain the aperture 48, 48 ain the closed configuration. In this respect, the reseal member 26, 26 amay be formed without the invertible distal portion 42, 42 a, with theradially inward biasing force being applied to the central portion 34,34 a by an O-ring which is received into the annular channel 50, 50 adefined between the proximal portion 28, 28 a and central portion 34, 34a.

Referring now to FIGS. 6-10, illustrated is a needleless injection site70 constructed in accordance with a second embodiment of the presentinvention. In the second embodiment, the injection site 70 preferablycomprises a Y-shaped housing 72, though the housing 72 may alternativelyhave a straight configuration. The housing 72 itself comprises a mainbody portion 74 which defines a proximal end 76, a distal end 78 and abore 80 extending axially therethrough. Extending angularly from themain body portion 74 is a tubular side arm portion 82 which is in fluidcommunication with the bore 80 of the main body portion 74. In typicalintravenous infusion applications, the side arm portion 82 of thehousing 72 is fluidly connected to a suspended solution bag via an uppersegment of tubular fluid line. The distal end 78 of the main bodyportion 74 is itself fluidly connected to a hollow introducer needle viaan elongate lower segment of tubular fluid line, thus allowing thesolution to flow from the bag into a target blood vessel via the uppertubing segment, injection site 70, lower tubing segment and introducerneedle.

Referring now to FIGS. 8-10, formed on and extending axially from theproximal end 76 of the main body portion 74 is an elongate dilatorprojection 84. The dilator projection 84 defines a longitudinallyextending fluid passage 86 which is in fluid communication with the bore80 and coaxially aligned therewith. Formed about the outer surface ofthe dilator projection 84 is a retaining lip 88 which has a generallytriangular cross-sectional configuration. Also formed on the proximalend 76 of the main body portion 74 is an annular flange 90 whichcircumvents the dilator projection 84. As best seen in FIG. 7, theflange 90 is formed on the proximal end 76 in a manner wherein thedilator projection 84 is centrally positioned therewithin. Additionally,as best seen in FIGS. 9 and 10, the flange 90 is formed in a mannerdefining an arcuately contoured rim which terminates at approximatelythe distal-most surface of the retaining lip 88.

In addition to the dilator projection 84 and flange 90, formed on theproximal end 76 of the main body portion 74 and extending radiallyoutward therefrom is a stop flange 92. Formed on the proximal surface ofthe stop flange 92 and extending perpendicularly relative thereto is anopposed pair of identically configured anti-rotation extensions 94. Theextensions 94 each have a height substantially equal to that of theflange 90 and extend in generally parallel relation thereto. Extendingradially from the peripheral edge of the stop flange 92 in opposedrelation is a pair of identically configured stop tabs 96. Formed aboutand extending radially outward from the outer surface of the main bodyportion 74 in opposed relation is a pair of leaf springs 98. The leafsprings 98, which are positioned on the main body portion 74, distallyfrom the stop flange 92, are thinly configured to provide the same withresiliency for reasons which will be discussed below. Also formed aboutand extending radially outward from the outer surface of the main bodyportion 74 in succession is a pair of identically configured centeringflanges 100 which are positioned on the main body portion 74 distallyfrom the leaf springs 98.

In the second embodiment, the housing 72 further comprises a hollowconnector cap 102 which is attached to the proximal portion of the mainbody portion 74. The connector cap 102 includes an annular attachmentregion 104 formed on the proximal end thereof. The attachment region 104defines a central opening 106 which communicates with the hollowinterior of the connector cap 102. Additionally, formed on the outersurface of the attachment region 104 are Luer threads 108. Theattachment of the connector cap 102 to the main body portion 74 isfacilitated by the receipt of the stop tabs 96 into an annular channel110 which is disposed within the inner surface of the connector cap 102and defines a proximal stop surface 112 and a distal stop surface 114.When the stop tabs 96 are properly received into the channel 110, theextensions 94 formed on the proximal surface thereof are received intocomplimentary slots 116 which are disposed within the inner surface ofthe connector cap 102 and extend longitudinally from the proximal stopsurface 112 of the channel 110 toward the proximal end of the connectorcap 102. As will be discussed in more detail below, the receipt of theextensions 94 into the slots 116 is operable to prevent the rotation ofthe connector cap 102 relative the main body portion 74.

In addition to the receipt of the stop tabs 96 into the channel 110, theperipheral portions of the leaf springs 98 are received into an annularchannel 118 which is also disposed in the inner surface of the connectorcap 102 and positioned distally from the channel 110. When the stop tabs96 and leaf springs 98 are received into the channels 110, 118, thedilator projection 84 extends axially into the central opening 106 ofthe connector cap 102, but does not protrude from the attachment region104 thereof. When the connector cap 102 is attached to the main bodyportion 74 in the aforementioned manner, the centering flanges 100 areadapted to maintain the main body portion 74 centrally within theconnector cap 102 such that the dilator projection 84, and in particularthe fluid passage 86 thereof, remains coaxially positioned within thecentral opening 106.

Referring now to FIGS. 7-10, disposed within the central opening 106 ofthe connector cap 102 and cooperatively engaged to the dilatorprojection 84 is reseal member 120 which is fabricated from a resilientmaterial. As best seen in FIGS. 7 and 8, the reseal member 120 comprisesa circularly configured proximal portion 122 which defines a top surface124 and includes a flange 126 formed about the periphery thereof. Thereseal member 120 further comprises a cylindrically configured centralportion 128 which defines a side surface 130 and a bottom surfaced 132having an elongate, generally concave recess 134 formed in the centerthereof. Importantly, the recess 134 has a shape complimentary to thatof the dilator projection 84 and defines an annular groove 136 withinits side wall. In addition to the proximal and central portions 122,128, the reseal member 120 comprises a tubular distal portion 138 whichincludes an annular lip 140 formed about the inner surface thereof. Alsoformed about the inner surface of the distal portion 138 immediatelyadjacent the bottom surface 132 of the central portion 128 is an annularextension 139. Extending from the top surface 124 of the proximalportion 122 to the apex of the recess 134 is an aperture 142 which iselastically openable and closable. In the injection site 70, the resealmember 120 normally resides in a closed position wherein the aperture142 is in a closed configuration.

To maintain the aperture 142 in the closed configuration, the distalportion 138 of the reseal member 120 is formed so as to be invertible inrelation to the remainder thereof. As best seen in FIG. 7, the distalportion 138, when inverted, is adapted to overlap the side surface 130of the central portion 128 and apply a radially inward biasing forcethereto which maintains the aperture 142 in the closed configuration.Such inversion is accomplished by initially turning the lip 140outwardly, thus causing the same to extend radially outward with respectto the remainder of the distal portion 138. Thereafter, the distalportion 138 is rolled toward the proximal portion 122, with the lip 140being inserted into the annular channel 144 defined between the proximaland central portions 122, 128. When the lip 140 is inserted into thechannel 144, the extension 139 extends radially outward with respect tothe remainder of the reseal member 120. When the distal portion 138 isproperly inverted, the reseal member assumes the configuration shown inFIG. 8. For ease of manufacture, the reseal member 120 is molded in theform shown in FIG. 7, with the distal portion 138 thereof being invertedin the aforementioned manner prior to the insertion of the reseal member120 into the central opening 106 and engagement thereof to the dilatorprojection 84. As previously explained, due to the resiliency of thematerial from which the reseal member 120 is fabricated, the inversionof the distal portion 138 facilitates the application of a radiallyinward biasing force to the central portion 128, thus maintaining theaperture 142 in the closed configuration.

In the injection site 70, the housing 72 further comprises an annularlock ring 146 for securing the reseal member 120 to the connector cap102, and in particular to the attachment region 104 thereof. Theattachment of the reseal member 120 to the connector cap 102 isaccomplished by the rigid capture of the flange 126 between the outersurface of the attachment region 104 and lock ring 146 which is itselfattached to the connector cap 102 via a sonic bonding process. Whenattached to the connector cap 102 via the lock ring 146, the centralportion 128 of the reseal member 120 (which is covered by the inverteddistal portion 138) resides within the central opening 106 and hollowinterior of the connector cap 102.

As previously indicated, in addition to being rigidly secured to theconnector cap 102, the reseal member 120 is cooperatively engaged to thedilator projection 84. In the injection site 70, such cooperativeengagement is achieved by the insertion of the dilator projection 84into the recess 134 of the reseal member 120. When the dilatorprojection 84 is fully inserted into the recess 134, the retaining lip88 formed thereabout is received into the groove 136 disposed within theside wall of the recess 134. When the retaining lip 88 is received intothe groove 136 the distal portion of the reseal member 120 is compressedinto and thus tightly contained within the annular space defined betweenthe dilator projection 84 and the flange 90, with the extension 139extending radially outward from the reseal member 120 being abuttedagainst the inner surface of the flange 90 and the distal end of thereseal member 120 being disposed in abutting contact with the proximalend 76 of the main body portion 74. Advantageously, the formation of theproximal rim of the flange 90 with an arcuate contour aids in theinsertion of the distal portion of the reseal member 120 into theannular space between the dilator projection 84 and flange 90. Thedistal portion of the reseal member 120 is maintained in the annularspace between the dilator projection 84 and the flange 90 in part by theretaining lip 88 which, when received into the groove 136, prevents themovement of the reseal member 120 proximally relative the dilatorprojection 84. As will be recognized, the engagement of the resealmember 120 to the dilator projection 84 typically occurs prior to theattachment thereof to the connector cap 102 via the lock ring 146.

The reseal member 120, due to its construction, is deformable such thatthe application of distally directed pressure thereto will cause it todistally advance within the central opening 106 to an open positionwherein the aperture 142 assumes an open configuration (as shown in FIG.10). Conversely, the removal of the distally directed pressure from thereseal member 120 will cause it to resiliently return to the closedposition wherein the aperture 142 assumes the closed configuration (asshown in FIG. 9). In particular, when the reseal member 120 is in theclosed position, the top surface 124 of the proximal portion 122 extendsover (i.e., covers) the proximal end of the attachment region 104, withthe aperture 142 being in the closed configuration due to the radiallyinward biasing force applied to the central portion 128 by the inverteddistal portion 138. When the tip 148 of an introducer device 150 (suchas a syringe or Luer connector as shown in FIG. 6) is used to applydistally directed pressure to the top surface 124 of the proximalportion 122, such pressure application causes the reseal member 120(with the exception of the flange 126) to distally advance within thecentral opening 106, as shown in FIG. 10.

The advancement of the reseal member 120 distally within the centralopening 106 causes the aperture 142 to be forced over the dilatorprojection 84 in a manner wherein the proximal tip of the dilatorprojection 84 protrudes from the top surface 124 of the proximal portion122 and is received into the outlet passage 152 of the introducer device150. The extension of the dilator projection 84 through the aperture 142allows fluid to flow from the outlet passage 152 of the introducerdevice 150 into the bore 80 via the fluid passage 86 of the dilatorprojection 84. Due to the resiliency of the reseal member 120, itsengagement to the dilator projection 84, and its rigid attachment to theattachment region 104, the removal of the introducer device 150 fromwithin the injection site 70 allows it to resiliently return to itsclosed position, thus causing the aperture 142 to once again assume theclosed configuration. In this respect, when no distally directedpressure is applied to the top surface 124 of the proximal portion 122,the aperture 142 is maintained in the closed configuration by theradially inward biasing force exerted on the central portion 128 by theinverted distal portion 138. The tip 148 of the introducer device 150 ispreferably sized having an outer diameter dimension which is slightlyless than the inner diameter dimension of the central opening 106, thusallowing the stretched region of the proximal portion 122 to form a sealbetween the outer surface of the tip 148 and the inner surface of thecentral opening 106.

In the injection site 70, the reseal member 120 is preferably fabricatedfrom silicone, though similar elastic materials such as rubber may beutilized as an alternative. Advantageously, the Luer threads 108 formedon the outer surface of the attachment region 104 allow introducerdevices such as Luer connectors to be interfaced to the injection site70. Additionally, the uniform top surface 124 defined by the proximalportion 122 when the reseal member 120 is in the closed position allowsfor the quick and easy cleaning and disinfection thereof.

Referring now to FIGS. 9 and 10, the main body portion 74 of the housing72 normally resides in a first position within the connector cap 102 (asshown in FIG. 9), and is adapted to move distally relative the connectorcap 102 to a second position therewithin when distally directed pressureis applied to the reseal member 120 (as shown in FIG. 10). When thedistally directed pressure is removed from the reseal member 120, themain body portion 74 is adapted to resiliently return to the firstposition. In the injection site 70, the main body portion 74 is biasedto the first position by the leaf springs 98 which are molded on theouter surface thereof and received into the channel 118 disposed in theinner surface of the connector cap 102. When distally directed pressureis applied to the reseal member 120, and in particular the top surface124 of the proximal portion 122, the main body portion 74 is moveddistally within the interior of the connector cap 102 toward its secondposition, thus resulting in the flexion of the leaf springs 98. Thedistal movement of the main body portion 74 within the connector cap 102is limited by the abutment of the stop tabs 96 against the distal stopsurface 114 defined by the channel 110. When such abutment occurs, themain body portion 74 resides in the second position. Importantly theanti-rotation extensions 94 are sized such that when the stop tabs 96are abutted against the distal stop surface 114, portions of theextensions 94 remain within their respective slots 116. The distallydirected pressure exerted on the top surface 124 of the proximal portion122 is transmitted to the main body portion 74 via the reseal member 120which, as previously indicated, is cooperatively engaged to the dilatorprojection 84 and abutted against the proximal end 76 of the main bodyportion 74.

When the distally directed pressure is removed from the top surface 124of the proximal portion 122, the leaf springs 98 returns to theiroriginal, unflexed positions which results in the movement of the mainbody portion 74 proximally within the connector cap 102, towards itsfirst position. The proximal movement of the main body portion 74 withinthe connector cap 102 is limited by the abutment of the stop tabs 96against the proximal stop surface 112 defined by the channel 110. Whensuch abutment occurs, the main body portion 74 resides in the firstposition. Importantly, the length of travel of the main body portion 74when it moves from the first to the second positions is significantlyless than the length of travel of the reseal member 120 when it movesfrom the closed position to the open position, thus allowing theaperture 142 of the reseal member 120 to be forced over the dilatorprojection 84 despite the distal movement of the main body portion 74within the connector cap 102. The return of the main body portion 74 tothe first position, though primarily being facilitated by the action ofthe leaf springs 98, is also aided by the reseal member 120. In thisrespect, due to the cooperative engagement of the reseal member 120 tothe dilator projection 84 as facilitated by the receipt of the retaininglip 88 into the groove 136, the resilient return of the reseal member120 to the closed position pulls the dilator projection 84, and hencethe main body portion 74, proximally toward the proximal end of theconnector cap 102.

Though not shown, it will be recognized that alternative means may beemployed to provide the radially inwardly biasing force to the centralportion 128 of the reseal member 120 to maintain the aperture 142 in theclosed configuration. In this respect, the reseal member 120 may beformed without the invertible, tubular distal portion 138, with theradially inwardly biasing force being applied to the central portion 128via an O-ring which is received into the annular channel 144 definedbetween the proximal and central portions 122, 128.

Referring now to FIGS. 11-17, illustrated is a needleless injection site160 constructed in accordance with a third embodiment of the presentinvention. As will be described in more detail below, the injection site160 is adapted to be selectively coupled to a Luer connector 162 (asshown in FIGS. 11 and 15), a standard tubular fluid line 164 (as shownin FIGS. 11 and 17), a Y-injection site (as shown in FIG. 16), and abottle 168 (as shown in FIG. 12). However, it will be recognized thatthe injection site 160 may additionally be fluidly coupled to variousother intravenous infusion components. The injection site 160 comprisesa housing 170 which itself comprises an adapter member 172 defining aproximal end 174, a distal end 176 and an interior chamber 178.

Referring now to FIGS. 14-17, the adapter member 172 comprises an uppersection 180 which defines the proximal end 174, and a lower section 182which is rigidly attached to the upper section 180 and defines thedistal end 176. The upper and lower sections 180, 182, when attached toeach other, define the interior chamber 178. When the upper and lowersections 180, 182 are rigidly attached to each other, the distal portionof the upper section 180 is concentrically positioned within theproximal portion of the lower section 182. Formed on the proximal end174 of the adapter member 172 is an elongate dilator projection 184which defines a proximal portion 186 extending axially from the proximalend 174, and a distal portion 188 extending axially into the interiorchamber 178. The dilator projection 184 further defines a longitudinallyextending fluid passage 190 which is in fluid communication with theinterior chamber 178. Formed about the outer surface of the proximalportion 186 of the dilator projection 184 is a retaining lip 192 whichhas a generally triangular cross-sectional configuration. The distalportion 188 of the dilator projection 184 preferably has a tapered outersurface for facilitating the connection of the housing 170 to the fluidline 164, as will be described in more detail below. Additionally, thedistal end of the distal portion 188 preferably has a beveledconfiguration defining a piercing tip 194. Formed on the tapered outersurface of the distal portion 188 and extending longitudinally from theproximal end 174 of the adapter member 172 to approximately the halfwaypoint of the distal portion 188 is an elongate rib 189, the use of whichwill also be discussed below.

In addition to the dilator projection 184, formed on the proximal end174 of the adapter member 172 and extending radially outward therefromis a stop flange 196. Formed on the proximal surface of the stop flange196 and extending perpendicularly relative thereto is an opposed pair ofidentically configured anti-rotation extensions 198. Additionally,formed about and extending radially outward from the outer surface ofthe adapter member 172, and in particular the upper section 180 thereof,is a leaf spring 200. The leaf spring 200, which is positioned on theupper section 180 distally from the stop flange 196, is thinlyconfigured to provide the same with resiliency for reasons which willalso be discussed below.

In the third embodiment, the housing 170 further comprises a hollowconnector cap 202 which is attached to the adapter member 172. Theconnector cap 202 includes an annular attachment region 204 formed onthe proximal end thereof. The attachment region 204 defines a centralopening 206 which communicates with the hollow interior of the connectorcap 202. Additionally, formed on the outer surface of the attachmentregion 204 are Luer threads 208. The attachment of the connector cap 202to the adapter member 172 is facilitated by the receipt of theperipheral portion of the stop flange 196 into an annular channel 210which is disposed within the inner surface of the connector cap 202 anddefines a proximal stop surface 212 and a distal stop surface 214. Whenthe stop flange 196 is properly received into the channel 210, theextensions 198 formed on the proximal surface thereof are received intocomplimentary slots 216 which are disposed within the inner surface ofthe connector cap 202 and extend longitudinally from the proximal stopsurface 212 of the channel 210 toward the proximal end of the connectorcap 202. As will be discussed in more detail below, the receipt of theextensions 198 into the slots 216 is operable to prevent the rotation ofthe connector cap 202 relative the adapter member 172.

In addition to the receipt of the stop flange 196 into the channel 210,the peripheral portion of the leaf spring 200 is received into anannular channel 218 which is also disposed in the inner surface of theconnector cap 202 and positioned distally from the channel 210. When thestop flange 196 and leaf spring 200 are received into the channels 210,218, the proximal portion 186 of the dilator projection 184 extendsaxially into the central opening 206 of the connector cap 202, but doesnot protrude from the attachment region 204 thereof. The lower section182 of the adapter member 172 is preferably sized having an outerdiameter dimension slightly less than the inner diameter dimension ofthe connector cap 202 for purposes of maintaining the adapter member 172centrally within the connector cap 202 such that the proximal portion186 of the dilator projection 184, and in particular the fluid passage190 thereof, remains coaxially positioned within the central opening206.

Referring now to FIGS. 13 and 17, disposed within the central opening206 of the connector cap 202 and cooperatively engaged to the proximalportion 186 of the dilator projection 184 is a reseal member 220 whichis fabricated from a resilient material. The reseal member 220 comprisesa tubular proximal portion 224 having an extension 226 formed about theouter surface thereof. The reseal member 220 further comprises acylindrically configured distal portion 228 which defines a top surface230, bottom surface 232 and side surface 234. Formed in the center ofthe bottom surface 232 is an elongate generally concave recess 236 whichhas a shape complimentary to that of the proximal portion 186 of thedilator projection 184 and defines an annular groove 238 within its sidewall. Extending from the top surface 230 of the distal portion 228 tothe apex of the recess 236 is an aperture 240 which is elasticallyopenable and closable. In the injection site 160, the reseal member 220normally resides in a closed position wherein the aperture 240 is in aclosed configuration.

To maintain the aperture 240 in the closed configuration, the proximalportion 224 of the reseal member 220 is formed so as to be invertible inrelation to the remainder thereof. As best seen in FIG. 13, the proximalportion 224, when inverted, is adapted to overlap the side surface 234of the distal portion 238 and apply a radially inward biasing forcethereto which maintains the aperture 240 in the closed configuration.Such inversion is accomplished by initially rolling the proximal portion224 toward the distal portion 228, and thereafter turning the extension226 outwardly so as to cause the same to extend radially outward withrespect to the remainder of the reseal member 220. When the proximalportion 224 is properly inverted, the reseal member assumes theconfiguration shown in FIG. 17. For ease of manufacture, the resealmember 220 is molded in the form shown in FIG. 13, with the proximalportion 224 thereof being inverted in the aforementioned manner prior tothe insertion of the reseal member 220 into the central opening 206 andthe engagement thereof to the proximal portion 186 of the dilatorprojection 184. As previously explained, due to the resiliency of thematerial from which the reseal member 220 is fabricated, the inversionof the proximal portion 224 facilitates the application of a radiallyinward biasing force to the distal portion 228, thus maintaining theaperture 240 in the closed configuration. When the reseal member 220 isfully inserted into the central opening 206 and cooperatively engaged tothe proximal portion 186 of the dilator projection 184, the distalportion 228 of the reseal member 220 ,(which is covered by the invertedproximal portion 224) resides within the central opening 206 and hollowinterior of the connector cap 202. Additionally, the top surface 230 ofthe reseal member 220, which has a slight arcuate contour, issubstantially flush with the proximal end of the attachment region 204.

As previously indicated, the reseal member 220 is cooperatively engagedto the proximal portion 186 of the dilator projection 184. In theinjection site 160, such cooperative engagement is achieved by theinsertion of the proximal portion 186 into the recess 236 of the resealmember 220. When the proximal portion 186 is fully inserted into therecess 236, the retaining lip 192 formed thereabout is received into thegroove 238 disposed within the side wall of the recess 236. When theretaining lip 192 is received into the groove 238, the distal portion ofthe reseal member 220 is forced between the proximal portion 186 and theextensions 198, with the extension 226 extending radially outward fromthe reseal member 220 being abutted against the inner surfaces of theextensions 198 and the distal end of the reseal member 220 beingdisposed in abutting contact with the proximal end 174 of the adaptermember 172. The reseal member 220 is tightly held by the proximalportion 186 of the dilator projection 184 and extensions 198 when forcedtherebetween in the aforementioned manner. The distal portion of thereseal member 220 is maintained between the proximal portion 186 and theextensions 198 in part by the retaining lip 192 which, when receivedinto the groove 238, prevents the movement of the reseal member 220proximally relative the proximal portion 186.

The reseal member 220, due to its construction, is deformable such thatthe application of distally directed pressure thereto will cause it todistally advance within the central opening 206 to an open positionwherein the aperture 240 assumes an open configuration (as shown inFIGS. 15 and 16). Conversely, the removal of the distally directedpressure from the reseal member 220 will cause it to resiliently returnto the closed position wherein the aperture 240 assumes the closedconfiguration (as shown in FIG. 17). When the reseal member 220 is inthe closed position, the top surface 230 thereof is substantially flushwith the proximal end of the attachment region 204, with the aperture240 being in the closed configuration due to the radially inward biasingforce applied to the distal portion 228 by the inverted proximal portion224. When the tip 242 of the introducer device 244 (such as a Luerconnector as shown in FIG. 15 and a syringe as shown in FIG. 16) is usedto apply distally directed pressure to the top surface 230, suchpressure application causes the reseal member 220 to distally advancewithin the central opening 206, as shown in FIGS. 15 and 16.

The advancement of the reseal member 220 distally within the centralopening 206 causes the aperture 240 to be forced over the proximalportion 186 of the dilator projection 184 in a manner wherein theproximal tip of the proximal portion 186 protrudes from the top surface230 of the distal portion 228 and is received into the outlet passage246 of the introducer device 244. The extension of the proximal portion186 through the aperture 240 allows fluid to flow from the outletpassage 246 of the introducer device 244 into and through the fluidpassage 190 of the dilator projection 184. Due to the resiliency of thereseal member 220 and its engagement to the dilator projection 184, theremoval of the introducer device 244 from within the injection site 160allows it to resiliently return to its closed position, thus causing theaperture 240 to once again assume the closed configuration. In thisrespect, when no distally directed pressure is applied to the topsurface 230 of the distal portion 238, the aperture 240 is maintained inthe closed configuration by the radially inward biasing force exerted onthe distal portion 238 by the inverted proximal portion 224.

In the injection site 160, the reseal member 220 is preferablyfabricated from silicone, though similar elastic materials such asrubber may be utilized as an alternative. The Luer threads 208 formed onthe outer surface of the attachment region 204 allow an introducerdevice 244 such as the Luer connector shown in FIG. 15 to be maintainedin coupled engagement to the injection site 160. Additionally, theuniform top surface 230 defined by the distal portion 228 when thereseal member 220 is in the closed position allows for the quick andeasy cleaning and disinfection thereof.

Referring now to FIGS. 15-17, the adapter member 172 of the housing 170normally resides in a first position within the connector cap 202 (asshown in FIG. 17), and is adapted to move distally relative theconnector cap 202 to a second position therewithin when distallydirected pressure is applied to the reseal member 220 (as shown in FIGS.15 and 16). When the distally directed pressure is removed from thereseal member 220, the adapter member 172 is adapted to resilientlyreturn to the first position. In the injection site 160, the adaptermember 172 is biased to the first position by the leaf spring 200 whichis molded on the outer surface of the upper section 180 thereof andreceived into the channel 210 disposed in the inner surface of theconnector cap 202. When distally directed pressure is applied to thereseal member 220, and in particular the top surface 230 of the distalportion 228, the adapter member 172 is moved distally within theinterior of the connector cap 202 toward its second position, thusresulting in the flexion of the leaf spring 200. The distal movement ofthe adapter member 172 within the connector cap 202 is limited by theabutment of the peripheral portion of the stop flange 196 against thedistal stop surface 214 defined by the channel 210. When such abutmentoccurs, the adapter member 172 resides in the second position.Importantly, the anti-rotation extensions 198 are sized such that whenthe stop flange is abutted against the distal stop surface 214, portionsof the extensions 198 remain within their respective slots 216. Thedistally directed pressure exerted on the top surface 230 of the distalportion 228 is transmitted to the adapter member 172 via the resealmember 220 which, as previously indicated, is cooperatively engaged tothe proximal portion 186 of the dilator projection 184 and abuttedagainst the proximal end 174 of the adapter member 172.

When the distally directed pressure is removed from the top surface 230of the distal portion 228, the leaf spring 200 returns to its originalunflexed position which results in the movement of the adapter member172 proximally within the connector cap 202 toward its first position.The proximal movement of the adapter member 172 within the connector cap202 is limited by the abutment of the peripheral portion of the stopflange 196 against the proximal stop surface 212 defined by the channel210. When such abutment occurs, the adapter member 172 resides in thefirst position. Importantly, the length of travel of the adapter member172 when it moves from the first to the second positions issignificantly less than the length of travel of the reseal member 220when it moves from the closed position to the open position, thusallowing the aperture 240 of the reseal member 220 to be forced over theproximal portion 186 of the dilator projection 184 despite the distalmovement of the adapter member 172 within the connector cap 202.Additionally, the anti-rotation extensions 198 are positioned on theproximal surface of the stop flange 196 so as to be longitudinallymovable within the slots 216 yet prevent the extension 226 of the resealmember 220 which is abutted against the inner surfaces thereof fromcontacting the inner surface of the connector cap 202. The return of theadapter member 172 to the first position, though primarily beingfacilitated by the action of the leaf spring 200, is also aided by thereseal member 220. In this respect, due to the cooperative engagement ofthe reseal member 220 to the proximal portion 186 of the dilatorprojection 184 as facilitated by the receipt of the retaining lip 192into the groove 238, the resilient return of the reseal member 220 tothe closed position pulls the dilator projection 184, and hence theadapter member 172, proximally toward the proximal end of the connectorcap 202.

Referring now to FIGS. 14 and 17, defined within the distal end 176 ofthe adapter member 172, and in particular the lower section 182 thereof,is a lock region for facilitating the connection of the injection site160 to an infusion component such as the Luer connector 162, Y-injectionsite 166 and bottle 168. The lock region of the adapter member 172preferably comprises three sets of Luer thread pitch barbs 248 which areformed on the inner surface of the lower section 182 in equidistantlyspaced intervals of approximately 120°. Each set of pitch barbs 248extends longitudinally from the distal end 176 of the adapter member 172into the interior chamber 178, and terminates at approximately thedistal end of the upper section 180. As best seen in FIG. 17, each setof pitch barbs 248 is formed within the lower section 182 so as to beoriented radially inward from the inner surface thereof.

As previously explained, the adapter member 172 of the housing 170 iscomprised of the upper and lower sections 180, 182 which are rigidlyattached to each other. In the third embodiment, the lower section 182of the adapter member 172 is molded to include a cover member 250 whichis attached to one of the sets of pitch barbs 248 via a tang 252. Thecover member 250 defines a tapered bore which is complimentary to thetapered outer surface of the distal portion 188 of the dilatorprojection 184. In this respect, subsequent to the assembly of theinjection site 160 in the aforementioned manner, the tang 252 ismanually broken, thus allowing the cover member 250 to be slidablyadvanced over the distal portion 188 of the dilator projection 184. Dueto the bore of the cover member 250 and the distal portion 188 havingmutually tapered configurations, the cover member 250 is frictionallymaintained upon the distal portion 188 subsequent to being slidablyadvanced over the same. Advantageously, the cover member 250 preventsany inadvertent contamination of the distal portion 188 prior to theincorporation of the injection site 160 into an intravenous infusionassembly. The cover member 250 also prevents a user from beinginadvertently injured by the piercing tip 194 of the distal portion 188.

In addition to the lower section 182 being molded with the cover member250, the connector cap 202 of the injection site 160 is molded toinclude a tubular adapter sleeve 254 which is attached to the proximalend of the attachment region 204 via three (3) equidistantly spacedtangs 256. The adapter sleeve 254 has a tapered outer surface 257 andincludes a tapered bore 258 extending longitudinally therethrough which,like the bore of the cover member 250, is complimentary to the taperedouter surface of the distal portion 188 of the dilator projection 184.Disposed within the side wall of the bore 258 are a plurality ofequidistantly spaced slots 260 which extend longitudinally from the endof the adapter sleeve 254 of greater diameter to a depth approximatelycommensurate with a shoulder 262 defined within the outer surface 257.As will be discussed in more detail below, the adapter sleeve 254 isused to facilitate the attachment of the injection site 160 to the Luerconnector 162. As will be recognized, the cover member 250 isnecessarily removed from the lower section 182 (or from upon the distalportion 188) and the adapter sleeve 254 removed from the connector cap202 prior to the utilization of the injection site 160.

As previously indicated, the injection site 160 is adapted to be engagedto the Luer connector 162, fluid line 164, Y-injection site 166 andbottle 168. As seen in FIG. 15, the engagement of the injection site 160to the Luer connector 162 is accomplished by slidably advancing theadapter sleeve 254 over the distal portion 188 of the dilator projection184 subsequent to the removal of the cover member 250 therefrom and thedetachment of the adapter sleeve 254 from the connector cap 202. Sincethe outer surface of the distal portion 188 and the bore 258 of theadapter sleeve 254 have mutually tapered configurations, the adaptersleeve 254 is frictionally maintained upon the distal portion 188subsequent to being slidably advanced over the same. Importantly, eachof the slots 260 is sized and configured to slidably receive the rib 189formed on the outer surface of the distal portion 188, with theadvancement of the adapter sleeve 254 proximally along the distalportion 188 being limited by the abutment of the distal end of the rib189 against the closed end of the slot 260 into which it is received.Advantageously, the receipt of the rib 189 into the slot 260 is operableto prevent the rotation of the adapter sleeve 254 upon the distalportion 188 of the dilator projection 184.

Subsequent to the attachment of the adapter sleeve 254 to the distalportion 188 in the aforementioned manner, the adapter sleeve 254 isslidably inserted into the lumen of the Luer connector 162. Theadvancement of the adapter sleeve 254 into the lumen of the Luerconnector 162 is continued until such time as the Luer threads formed onthe outer surface of the Luer connector 162 are engaged by the pitchbarbs 248 of the lock region. Due to the tapered outer surface 257 ofthe adapter sleeve 254, the same is frictionally maintained within thelumen of the Luer connector 162 subsequent to being inserted thereinto.Additionally, the Luer connector 162 is prevented from being pulleddistally away from the adapter member 172, and in particular the adaptersleeve 254, by the engagement of the pitch barbs 248 to the Luer threadsthereof. As such, the combination of the frictional retention of theadapter sleeve 254 within the lumen and the engagement of the pitchbarbs 248 to the Luer threads creates a secure interface between theinjection site 160 and the Luer connector 162. When the reseal member220 is moved to the open position, fluid flows from the outlet passage246 of the introducer device 244 into the lumen of the Luer connector162 via the fluid passage 190 of the dilator projection 184 and bore 258of the adapter sleeve 254.

Referring now to FIG. 16, the engagement of the injection site 160 tothe Y-injection site 166 is accomplished by initially removing the covermember 250 from the distal portion 188 of the dilator projection 184,and removing the adapter sleeve 254 from the connector cap 202.Thereafter, the injection site 160, and in particular the adapter member172 thereof, is advanced over the top end of the Y-injection site 166 ina manner wherein the distal portion 188 of the dilator projection 184 isextended into the Y-injection site 166 (with any diaphragm attached tothe top end thereof being pierced by the piercing tip 194 of the distalportion 188). In addition to the distal portion 188 of the dilatorprojection 184 being extended into the Y-injection site 166, theenlarged end region of the Y-injection site 166 is captured within thepitch barbs 248, thus preventing the movement thereof distally away fromthe adapter member 172 and removal of the distal portion 188 fromtherewithin. When the reseal member 220 is moved to the open position,fluid flows from the outlet passage 246 of the introducer device 244into the Y-injection site 166 via the fluid passage 190 of the dilatorprojection 184. Though not shown in detail, the engagement of theinjection site 160 to the neck of the bottle 168 occurs in the samemanner as described in relation to the Y-injection site 166.

As seen in FIG. 17, the engagement of the injection site 160 to thetubular fluid line 164 is accomplished by initially removing the covermember 250 from the distal portion 188 of the dilator projection 184,and removing the adapter sleeve 254 from the connector cap 202.Thereafter, the distal portion 188 of the dilator projection 184 isslidably advanced into the lumen of the fluid line 164. Due to thetapered outer surface of the distal portion 188, the same isfrictionally maintained within the fluid line 164 subsequent to beinginserted into the lumen thereof. When the reseal member 220 is moved tothe open position, fluid flows from the introducer device into the fluidline 164 via the fluid passage 190 of the dilator projection 184.

Additional modifications and improvements of the present invention mayalso be apparent to those skilled in the art. Thus, the particularcombination of parts described and illustrated herein is intended torepresent only certain embodiments of the present invention, and is notintended to serve as limitations of alternative devices within thespirit and scope of the invention.

1. A needleless injection site including: a housing including a mainbody portion with a proximal end, a distal end and a bore extendingthere through; a reseal member disposed in the bore and attached to themain body portion at the proximal end, the reseal member having asubstantially planar face, a second face opposite the first face, and anelastically openable and closable aperture formed therein and normallyresiding in a closed position wherein the aperture is in a closedconfiguration which prevents fluid flow there through, the substantiallyplanar face having a diameter at least substantially equal to a diameterof the bore when the aperture is in the closed position; said resealmember being attached to the main body portion such that only theapplication of distally directed force to the substantially planar facewill cause the aperture to assume an open configuration, whereinmovement of the second face is unimpeded within the bore, and theremoval of only the distally directed force therefrom will allow theaperture to return to the closed configuration.
 2. A needlelessinjection site including: a housing with a main body portion having aproximal end, a distal end and a bore extending there through; a resealmember having a circularly configured substantially planar proximalportion and a substantially planar central portion, wherein the proximalportion is attached to the main body portion and the central portion isdisposed in the bore, the reseal member having an elastically openableand closable aperture formed therein and normally residing in a closedposition, wherein when the aperture is in a closed configuration fluidflow there through is prevented, the substantially planar face having adiameter at least substantially equal to a diameter of the bore when theaperture is in the closed position, the reseal member further having adistal portion opposite the substantially planar central portion; saidreseal member being attached to the main body portion such that onlyadvancement of the reseal member distally within the bore causes thesubstantially planar proximal portion to exert a force on thesubstantially planar central portion such that only the force on thesubstantially planar central portion causes the aperture to assume anopen configuration, wherein movement of the distal portion is unimpededwithin the bore.
 3. A needless injection site, comprising: a housing;and a reseal member having a substantially planar first face attached tothe housing, said reseal member having an elastically openable andclosable aperture formed therein and normally residing in a closedposition wherein the aperture is in a closed configuration, thesubstantially planar face having a diameter at least substantially equalto a diameter of the bore when the aperture is in the closed position;said reseal member being deformable such that only the application ofdistally directed pressure to the substantially planar first face willcause the aperture to assume an open configuration, and only the removalof the distally directed pressure therefrom will allow the aperture toreturn to the closed configuration; wherein said reseal membercomprises: a flange formed about the periphery of the reseal member; anda central portion having a notch in a second face opposite the firstface, wherein the notch is an empty cavity, and movement of the secondface is unimpeded within the bore.